MedPath

Kids Silly Strawberry TP

5820011 HEb Kid's Strawberry w/Fluroide TP (80-15276)

Approved
Approval ID

ab361305-01f9-7379-e053-2995a90a97b4

Product Type

HUMAN OTC DRUG LABEL

Effective Date

Aug 12, 2025

Manufacturers
FDA

HEB

DUNS: 007924756

Products 1

Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.

Sodium monofluorophosphate

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code37808-411
Application NumberM021
Product Classification
M
Marketing Category
C200263
G
Generic Name
Sodium monofluorophosphate
Product Specifications
Route of AdministrationDENTAL
Effective DateAugust 12, 2025
FDA Product Classification

INGREDIENTS (7)

HYDRATED SILICAInactive
Code: Y6O7T4G8P9
Classification: IACT
SODIUM MONOFLUOROPHOSPHATEActive
Quantity: 0.13 g in 100 g
Code: C810JCZ56Q
Classification: ACTIM
CALCIUM CARBONATEInactive
Code: H0G9379FGK
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
SODIUM LAUROYL SARCOSINATEInactive
Code: 632GS99618
Classification: IACT
CARRAGEENANInactive
Code: 5C69YCD2YJ
Classification: IACT
GLYCERINInactive
Code: PDC6A3C0OX
Classification: IACT

Drug Labeling Information

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

LOINC: 51945-4Updated: 7/24/2020

Tube Artwork

INDICATIONS & USAGE SECTION

LOINC: 34067-9Updated: 7/24/2020

Helps protect against cavities

OTC - ACTIVE INGREDIENT SECTION

LOINC: 55106-9Updated: 7/24/2020

Sodium monofluorophosphate 0.76% (0.13% fluoride ion)

OTC - PURPOSE SECTION

LOINC: 55105-1Updated: 7/24/2020

Anticavity

WARNINGS SECTION

LOINC: 34071-1Updated: 7/24/2020

Keep out of reach of children under 6 years of age. If more than used for brushing is accidentally swallowed, get medical help or contact a Poison Control Center right away.

DOSAGE & ADMINISTRATION SECTION

LOINC: 34068-7Updated: 7/24/2020

Adults and children 2 years of age and older: brush teeth thoroughly, preferably after each meal or at least twice a day, or as directed by a dentist or doctor

  • do not swallow

  • to minimize swallowing use a pea-sized amoutn in children under 6

  • supervise children's brushing until good habits are established

Children under 2 years of age: consult a dentist or doctor.

INACTIVE INGREDIENT SECTION

LOINC: 51727-6Updated: 7/24/2020

glycerin, water, calcium carbonate, hydrated silica, natural flavor, carrageenan, sodium lauroyl sarcosinate

OTHER SAFETY INFORMATION

LOINC: 60561-8Updated: 7/24/2020

Store in a cool, dry place. Keep tube capped when not in use.

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Kids Silly Strawberry TP - FDA Drug Approval Details